Assessing Safety of COVID-19 mRNA Vaccine Administration in the Setting of a Previous Adverse Reaction

HUM00206480

This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal history of allergic reaction. In addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to a natural COVID-19 infection ("long COVID"). Eligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalent vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits. We hypothesize that individuals who have had adverse reactions to a previous dose of an mRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mRNA COVID-19 bivalent vaccine, as indicated. The study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.

2022-03-21

2024-12-30

2024-12-30

Recruiting

Early phase I

200

Inclusion Criteria 1. Age over 18. 2. Participant must be able to understand and provide informed consent 3. No evidence of infectious illness (defined as fever \>38⁰C, vomiting, diarrhea, new cough, new shortness of breath, new congestion, new runny nose, new headache or sore throat) within 14 days of vaccine administration. 4. Subjects must have a history of adverse reaction to either the Pfizer-BioNTech mRNA COVID vaccination or the Moderna mRNA COVID vaccination, a personal history of allergic reaction without prior mRNA COVID vaccination, or a history of adverse reaction to natural COVID infection. 5. Females of childbearing potential must have a negative pregnancy test prior to vaccination. Exclusion Criteria 1. Under age 18 2. Inability or unwillingness of a participant to give written informed consent 3. Evidence of COVID-19 infection within 21 days of vaccination visit 4. History of antibody agent or convalescent plasma for treatment or prevention of COVID-19 within 90 days 5. Individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech mRNA COVID-19 vaccination or the Moderna mRNA COVID-19 vaccination. 6. History of underlying immune disorder. * Pregnancy * Immunocompromised * Persons with primary or acquired immunodeficiency * Persons on anti-rejection therapy following solid organ transplant or bone marrow transplant * Persons on biologic therapeutic agents * Persons with malignancy and ongoing or recent chemotherapy * Persons receiving systemic immunosuppressive therapy, including corticosteroids equivalent to 20 mg/day of prednisone for 2 weeks * Persons with chronic kidney disease stage 3 or higher * Persons with history of significant pulmonary compromise

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2024-05-17